Achilles Non-SNIS REGENETEN

NCT07869121 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 1181
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study addresses this gap by prospectively evaluating patient-reported outcomes, imaging endpoints, and safety through 12 months after BCI-augmented repair in IAT and MSR patients. The purpose is to evaluate clinical outcomes (effectiveness) following the use of REGENETEN to augment Achilles tendon surgical procedures.

Conditions

Complete Mid-portion Achilles Rupture

Keywords

achilles rupture; achilles; rupture; Regeneten; Achilles Tendinopathy

Outcome Measures

Primary Outcomes (1)

• American Orthopaedic Foot & Ankle Society (AOFAS) ankle/hindfoot score

  AOFAS ankle/hindfoot score - Clinician reported score completed at 12 months post Achilles surgical procedure. Scores range from 0 to 100, with healthy ankles receiving 100 points

  12 months post surgery

Secondary Outcomes (7)

• Tendon healing at site of procedure

  12 months post surgery

• Implant absorption

  12 months post surgery

• Tendon thickness

  12 months post surgery

• Achilles Tendon Total Rupture Score (ATRS)

  preop/screening, 6 week postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative

• Victorian Institute of Sport Assessment Achilles (VISA-A)

  6 weeks postoperative , 3 months postoperative, 6 months postoperative, and 12 months postoperative

Other Outcomes (3)

• Achilles Tendon Resting Angle (ATRA)

  preoperative/screening, 3 months postoperative, 6 months postoperative, and 12 months postoperative

• Range of Motion (ROM)

  preoperative/screening, 3 months, 6 months, and 12 months postoperative

• Charlotte Hindfoot Assessment

  preoperative/screening, 6 weeks postoperative, 3 months postoperative, 6 months postoperative, and 12 months postoperative

Study Arms (2)

Krakow sutured, bundle-to-bundle repair

Krakow sutured, bundle-to-bundle repair for mid-substance primary Achilles rupture with REGENETEN augmentation. Fixation of REGENETEN implant to be completed with tendon anchors.

Device: REGENETEN

Achilles tendon reconstruction

Achilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors.

Device: REGENETEN

Interventions

REGENETEN DEVICE

The REGENETEN Bioinductive Implant is a scaffold made from highly purified type I collagen fibers. Following fixation, using its efficient and suture-free technique, the REGENETEN Implant is resorbed and replaced by a new layer of tendon-like tissue within 6 months increasing tendon thickness, and creating an environment conducive to healing.

Achilles tendon reconstruction; Krakow sutured, bundle-to-bundle repair

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who present as eligible for Krakow sutured, bundle-to-bundle repair for mid-substance primary Achilles rupture with REGENETEN augmentation. Fixation of REGENETEN implant to be completed with tendon anchors. Patients who present as eligible for Achilles tendon reconstruction, with or without concomitant calcaneoplasty/bursectomy for insertional Achilles tendinopathy. Fixation of REGENETEN implant to be completed with tendon anchors.

You may qualify if:

• Acute Mid-Substance Rupture:
• Clinical diagnosis of complete mid-portion Achilles rupture by experienced physician (Diagnosis confirmation to include presence of positive Thompson test)
• Adult patients ≥21 to 70 years old
• Acute rupture (≤14 days of initial injury)
• Rupture located 2-6cm proximal to calcaneal insertion mid portion
• Indicated for surgical procedure
• Insertional Achilles Tendinopathy:
• Diagnosis of insertional Achilles tendinopathy confirmed by imaging and having failed at least 3 months of conservative management.
• Adult patients ≥21 to 70 years old
• Indicated for surgical procedure

You may not qualify if:

• Achilles tendon retraction \>3cm (Kuwada grade II)
• Avulsion injury
• Pregnancy or planning to become pregnant
• Previously known reaction to bovine
• Concurrent lower extremity fracture/ acute polytrauma
• Local injections (corticosteroid or biologic) within 6-months of rupture on the injured achilles
• Fluoroquinolone use within last 6 months
• Diabetes (uncontrolled)
• HTN (uncontrolled)
• Current smoking
• Skin problems over Achilles
• Current infection
• Open Achilles rupture
• Neurovascular disease
• Neurological disorder (eg stroke)

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Related Publications (8)

• Genuth G, Iselin LD. Treating insertional Achilles tendinitis with bio inductive collagen scaffold - Does it improve outcomes? A case series. J Clin Orthop Trauma. 2025 Feb 7;63:102931. doi: 10.1016/j.jcot.2025.102931. eCollection 2025 Apr.

  PMID: 40041090 BACKGROUND

• Moonot P, Dakhode S. Current concept review of Achilles tendinopathy. J Clin Orthop Trauma. 2024 Feb 23;50:102374. doi: 10.1016/j.jcot.2024.102374. eCollection 2024 Mar.

  PMID: 38463138 BACKGROUND

• Shoap S, Backer HC, Freibott CE, Ferrer XE, Polzer H, Turner Vosseller J. Rerupture and wound complications following Achilles tendon repair: A systematic review. J Orthop Res. 2023 Apr;41(4):845-851. doi: 10.1002/jor.25419. Epub 2022 Aug 6.

  PMID: 35864743 BACKGROUND

• Lo IK, Kirkley A, Nonweiler B, Kumbhare DA. Operative versus nonoperative treatment of acute Achilles tendon ruptures: a quantitative review. Clin J Sport Med. 1997 Jul;7(3):207-11. doi: 10.1097/00042752-199707000-00010.

  PMID: 9262889 BACKGROUND

• Sharma P, Maffulli N. Tendon injury and tendinopathy: healing and repair. J Bone Joint Surg Am. 2005 Jan;87(1):187-202. doi: 10.2106/JBJS.D.01850.

  PMID: 15634833 BACKGROUND

• Lemme NJ, Li NY, DeFroda SF, Kleiner J, Owens BD. Epidemiology of Achilles Tendon Ruptures in the United States: Athletic and Nonathletic Injuries From 2012 to 2016. Orthop J Sports Med. 2018 Nov 26;6(11):2325967118808238. doi: 10.1177/2325967118808238. eCollection 2018 Nov.

  PMID: 30505872 BACKGROUND

• Traweger A, Scott A, Kjaer M, Wezenbeek E, Scattone Silva R, Kennedy JG, Butler JJ, Gomez-Florit M, Gomes ME, Snedeker JG, Dakin SG, Wildemann B. Achilles tendinopathy. Nat Rev Dis Primers. 2025 Mar 27;11(1):20. doi: 10.1038/s41572-025-00602-9.

  PMID: 40148342 BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

MeSH Terms

Conditions

Rupture

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Carroll Jones, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2026
• First Posted: October 9, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

US (1)